Early Amiodarone in Shockable Cardiac Arrest

NCT06680869 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: STUDY000264551K23HL173647-01
• Study Type: interventional
• Target: 585
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care.

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Time from emergency medical services (EMS) arrival on-scene (or time of arrest if witnessed by EMS) to the administration of the initial dose of amiodarone in minutes

  up to 1 day

Secondary Outcomes (7)

• The number and proportion of patients receiving the initial dose of amiodarone from emergency medical services before the third shock from a defibrillator

  up to 1 day

• The number and proportion of patients with pulses present and documented by emergency medical services at the time of patient care transfer to hospital staff at emergency department arrival

  up to 1 day

• The number and proportion of patients surviving to be admitted to inpatient services after arrival to the emergency department

  up to 1 day

• The number and proportion of patients surviving to be discharged from the hospital (or 30 days, whichever is sooner) after their admission for cardiac arrest

  up to 30 days

• The number and proportion of patients surviving to be discharged from the hospital (or 30 days, whichever is sooner) after their admission for cardiac arrest with a Cerebral Performance Category score of 1 or 2

  up to 30 days

Study Arms (2)

Early Amiodarone Protocol

EXPERIMENTAL

Amiodarone administration after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine.

Drug: Amiodarone Hydrochloride Injection

Usual Care Protocol

ACTIVE COMPARATOR

Amiodarone administration after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine.

Other: Usual Care Protocol

Interventions

Usual Care Protocol OTHER

The use of a usual care treatment protocol by emergency medical services where the initial dose of amiodarone is given after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine, for out-of-hospital cardiac arrest due to a shockable rhythm (ventricular fibrillation or ventricular tachycardia) that is persistent or recurs after at least one defibrillation attempt. If an EMS agency is assigned to this arm, no downstream care after the initial dose of amiodarone is dictated by the study.

Usual Care Protocol

Amiodarone Hydrochloride Injection DRUG

The use of a modified treatment protocol by emergency medical services where the initial dose of amiodarone is given after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine, for out-of-hospital cardiac arrest due to a shockable rhythm (ventricular fibrillation or ventricular tachycardia) that is persistent or recurs after at least one defibrillation attempt. If an EMS agency is assigned to this arm, no downstream care after the initial dose of amiodarone is dictated by the study.

Also known as: Early-Amiodarone Protocol

Early Amiodarone Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emergency medical services (EMS)-treated non-traumatic out-of-hospital cardiac arrest
• Initial rhythm on EMS rhythm assessment of ventricular fibrillation or ventricular tachycardia
• Recurrence or persistence of ventricular fibrillation or ventricular tachycardia after one defibrillation attempt

You may not qualify if:

• Known allergy to amiodarone
• EMS-assessed contraindication to amiodarone
• Pre-existing "do-not-attempt-resuscitation" orders
• Inter-facility transportations
• Initial care by a non-participating EMS agency able to perform advanced life support interventions
• Pediatric patient as determined by EMS
• Prisoners
• Pregnant patients

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Oregon Health & Sciences University

Portland, Oregon, 97035, United States

RECRUITING

Related Links

• Early-Amio Study Website

MeSH Terms

Conditions

Heart Arrest

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joshua Lupton, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Lupton, MD, MPH

CONTACT

(503) 418-6706; lupton@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 12 months from study completion. No end date.
• Access Criteria: Per NHLBI BioLINCC policy

Locations

US (1)